510(k) · Cleared
ClearedThe Dimension Vista Flex Reagent Cartridges / Kit Assays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Cleared on Aug 21, 2006 as substantially equivalent to K943024 (Dupont Medical Products, 1994) and 10 other predicates after a 26-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Aug 21, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- JHS
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 4 generations to K010496 (2001). 20 ancestors in all, the oldest K943024 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK010496 Cedia Dau Amphetamines/Ecstasy AssayMicrogenics Corp. · 2001
- 3 generations backK012110 Dri Ecstasy Enzyme ImmunoassayMicrogenics Corp. · 2001
- 2 generations backK043028 Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005
- 1 generation backK053337 Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc. · 2006
- This deviceK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK102045 Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010496 | Cedia Dau Amphetamines/Ecstasy Assay | Microgenics Corp. | 2001 | — |
| −3 | K012110 | Dri Ecstasy Enzyme Immunoassay | Microgenics Corp. | 2001 | — |
| −2 | K043028 | Emit II Plus Ecstasy Assay | Dade Behring, Inc. | 2005 | — |
| −1 | K053337 | Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109 | Dade Behring, Inc. | 2006 | — |
| 0 (this device) | K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Dade Behring, Inc. | 2006 | — |
| +1 | K102045 | Dimension Visa HBA1C, Model K3105A | Siemens Heatlhcare Diagnostics, Inc. | 2011 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JHS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (11)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943024 | Kinase IsoenzymeSummary page 2…51~~# Code Dimension VistaTM Dimension® Flex® CKMB Flex® CKMB reagent cartridge K943024 I1 862.1215 JHS reagent cartridg e Dimension Vista TM Dimension® K011852 864.7… | 1994 |
| * | K011852 | Dimension Haic Assay, Model DF105Summary page 2…® Flex® CKMB Flex® CKMB reagent cartridge K943024 I1 862.1215 JHS reagent cartridg e Dimension Vista TM Dimension® K011852 864.7470 LCP HAIC Kit HAIC Kit Dimension VistaTM Dimension® Flex® AMPH Flex®… | 2001 |
| * | K040133 | Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeSummary page 2…K011852 864.7470 LCP HAIC Kit HAIC Kit Dimension VistaTM Dimension® Flex® AMPH Flex® AMPH reagent cartridge K040133 II 862.3100 DKZ reagent cartidge Dimension VistaTM Dimension® Flex® BARB Flex® reagent BARB reage… | 2004 |
| * | K000459 | Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog NO. DF 96ASummary page 2…agent cartridge K040133 II 862.3100 DKZ reagent cartidge Dimension VistaTM Dimension® Flex® BARB Flex® reagent BARB reagent cartridge K000459 II 862.3150 DIS cartridge Dimension VistaTM Dimension® Flex® BENZ Flex® reagent BENZ reagent cart… | 2000 |
| * | K000458 | Urine Benzodiazepines (Benz) Screen Flex Reagent Cartridge, Catalog NO. DF 92ASummary page 2…BARB reagent cartridge K000459 II 862.3150 DIS cartridge Dimension VistaTM Dimension® Flex® BENZ Flex® reagent BENZ reagent cartridge K000458 11 862.3170 JXM cartridge Dimension VistaTM Dimension® Flex® COC Flex® reagent COC reagent cart… | 2000 |
| * | K033713 | Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92ASummary page 2…ENZ reagent cartridge K000458 11 862.3170 JXM cartridge Dimension VistaTM Dimension® Flex® COC Flex® reagent COC reagent cartridge K033713 11 862.3250 DIO cartridge Dimension VistaTM Dimension® Flex® EXTC Flex® reagent EXTC reagent cart… | 2004 |
| * | K053337 | Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Summary page 2…COC reagent cartridge K033713 11 862.3250 DIO cartridge Dimension VistaTM Dimension® Flex® EXTC Flex® reagent EXTC reagent cartridge K053337 II 862.3100 DKZ cartridge Dimension VistaTM Dimension® Flex® METH Flex® METH reagent cart… | 2006 |
| * | K000466 | Urine Methadone (Meth) Screen Flex Reagent Cartridge, Catalog NO. DF 93ASummary page 2…EXTC reagent cartridge K053337 II 862.3100 DKZ cartridge Dimension VistaTM Dimension® Flex® METH Flex® METH reagent cartridge K000466 II 862.3620 DJR reagent cartrid e Dimension VistaTM Dimension® Flex® OPI Flex® reagent OPI reage… | 2000 |
| * | K003209 | Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog NO. DF93ASummary page 2…gent cartridge K000466 II 862.3620 DJR reagent cartrid e Dimension VistaTM Dimension® Flex® OPI Flex® reagent OPI reagent cartridge K003209 II 862.3650 DJG cartridge . . Dimension VistaTM Dimension® Flex® PCP Flex® reagent PCP re… | 2000 |
| * | K000462 | Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO. DF 94ASummary page 2…cartridge K003209 II 862.3650 DJG cartridge . . Dimension VistaTM Dimension® Flex® PCP Flex® reagent PCP reagent cartridge K000462 II 862.3100 LCM cartridge Dimension VistaTM Dimension® Flex® THC Flex® reagent THC reagent cartr… | 2000 |
| * | K000461 | Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog NO. DF 95ASummary page 2…PCP reagent cartridge K000462 II 862.3100 LCM cartridge Dimension VistaTM Dimension® Flex® THC Flex® reagent THC reagent cartridge K000461 II 862.3870 LDJ cartridge . . Device Description: Dade Behring Dimension VistaTM Flex® reagent car… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102045 | Dimension Visa HBA1C, Model K3105A | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K102045 (Siemens Heatlhcare Diagnostics, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JHS devicesJHS Differential Rate Kinetic Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JHS
Too few JHS 510(k)s in any year since 2007 to give a median.
Recalls per year · JHS
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHS
10in 2025
MAUDE reports naming product code JHS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 26 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 2 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 5 | 6 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 1 | 13 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dimension VistaTM Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge is a device intended to measure the activity of the creatine kinase MB isoenzyme in plasma and serum. Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The HAIC assay used on the Dimension Vista rMintegrated system is an in-vitro diagnostic…
Read the full statement (1,161 words)
The Dimension VistaTM Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge is a device intended to measure the activity of the creatine kinase MB isoenzyme in plasma and serum. Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
The HAIC assay used on the Dimension Vista rMintegrated system is an in-vitro diagnostic assay for the quantitative determination of percent hemoglobin A I c(HbA l c) in anticoagulated whole blood. Measurements of percent hemoglobin Alc are effective in monitoring long term glucose control in individuals with diabetes mellitus.
The AMPH Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.
The AMPH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The BARB Flex®reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of barbiturates in human urine. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose.
The BARB method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The BENZ Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of benzodiazepines in human urine. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
The BENZ method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The COC Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semti-quantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COG method are used in the diagnosis and treatment of cocaine use or overdose.
The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The EXTC Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of methylenedioxymethamphetamine (MDMA), and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose.
The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The METH Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone in human urine. Measurements obtained with the METH method are used to detect methadone use or overdose and to determine compliance with methadone maintenance treatment.
The METH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The OPI Flex® reagent cartridge (300 ng/mL cutoff) used on the Dimension Vista rM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of opiates in human urine. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose.
The OPI method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The PCP Flex® reagent cartridge used on the Dimension VistaTm integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.
The PCP method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The THC Flex® reagent cartridge used on the Dimension VistaTm integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of cannabinoids in human urine. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose.
The TIHC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062128
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026